Following the announcement by Samsung Biologics that it planned to add mRNA vaccine drug substance manufacturing services to its offering, DDW’s Megan Thomas spoke to Seahee Kim about what this means for both business and drug development.
MT: As a CDMO, Samsung Biologics can offer both development and manufacturing services. What are the advantages of this end-to-end service partnership in relation to drug discovery and development?
Partnering with a full service CDMO like Samsung Biologics, which has integrated capabilities and approaches to drug development and manufacturing, means that the tech transfer process can be greatly optimised when compared to multi-vendors, enabling the drug developers to save time, costs and resources.
An end-to-end CDMO partner offers a full spectrum of operations that allows them to identify and manage challenges in the early phase of drug development with commercialisation in mind. This subsequently minimises barriers and accelerates the journey to the market.
MT: How does the way the business is set up get drugs to market faster?
We offer a fully integrated solution to take our clients through the complete drug development lifecycle and into commercial manufacturing. With extensive expertise and streamlined project management, we ensure flexibility and full scalability to enable the drugs to reach the market successfully within an expedited timeline. Our innovative technology and equipment also allow for a more efficient screening and optimisation, which saves us significant time at each step of the process.
As mentioned above, at the development phase, we can expedite the timeline by utilising development, manufacturing and testing services that we have in-house. S-CHOice, Samsung Biologics’ proprietary cell line technology, was launched last year to provide even more promising options when bringing the clients’ molecules faster and better to the market.
We are then able to scale up the drug with seamless tech transfer from our CDO business to our CMO business, where drugs can be manufactured in both small and large batches ranging from 1,000 liters to 15,000 liters as needed. Samsung Biologics currently offers multi-scale capacity to clients with our combined total manufacturing capacity of 364,000L, the world’s largest manufacturing capability at a single site. This will increase further upon completion of Plant 4.
In addition, by providing a fully-integrated one stop service from development to manufacturing and testing, we allow our clients to focus more of their time and resources on drug discovery rather than investing in large construction projects needed to add manufacturing capacity to bring their products to market faster.
MT: Samsung Biologics plans to add mRNA vaccine drug substance (DS) manufacturing capability to its current facility in Songdo, ready for cGMP operations within early 2022. What will this mean for drug development – how is the business working with this section of the market?
The emergency use authorisation of new mRNA vaccines was truly a game-changing moment in the life science industry, and it has opened the door to new breakthrough possibilities. That said, this new type of therapeutic modality has different challenges and requires different skills. Our extended manufacturing capability, which includes mRNA DP and soon DS, will enable us to help clients access our expertise and take advantage of our quality operations by sharing the modality-specific insights and critical success factors during the development journey. Given mRNA’s unique cell-free synthetic process, this could significantly save time in development and manufacturing.
MT: What was the purpose of Samsung Biologics opening its newest US R&D Centre in San Francisco? What does it hope to achieve?
The opening of our first R&D centre in San Francisco is aimed to bring our contract development services closer to global clients as their “Next Door CDO Partner.” Since the drug development journey is a complex, long, and rigorous process, prompt and transparent communication between the client and CDMO partner is vital to ensure success. The Bay Area is also unique in terms of new technology development by pharma companies. We are also hoping to adopt new technology for our US R&D centre to further advance Samsung Biologics’ research capabilities.
MT: This R&D centre is in the heart of the San Francisco bio-cluster. How does Samsung Biologics benefit from this proximity to biotech and pharmaceutical companies in the Bay Area? What does Samsung Biologics bring to those already there?
Tapping into South San Francisco, the birthplace of biotech and one of the fastest developing bioclusters, Samsung Biologics will provide real-time interaction and be in closer proximity to potential and existing clients in the region. Aligned with the company’s mission to offer a seamless one-stop service, the new facility will utilise the same CDO research and development capabilities present at our headquarters in Incheon, South Korea. With these services available, we can guide biotechs and pharmaceutical companies through a seamless transition from the development stages to commercial manufacturing.
Samsung Biologics’ CDO business aims to bring quality-driven development services at a greater speed with expedited timelines, delivering cell line development to DS manufacturing in six months, and to DP manufacturing in seven months – the fastest pace in the industry. Samsung Biologics America also provides the highest quality cell lines to produce antibody or protein drugs for our clients.
MT: Where does the company see drug development opportunities for mRNA products and biologics in the near future?
Without a doubt, the biggest scientific breakthrough of 2020 was the emergency use authorisation of mRNA vaccines, following more than a decade of research & development into mRNAs. The interest for these products will continue to grow rapidly with the emergence of other new life-threatening diseases and work to tackle existing diseases. Accordingly, we will need to expand the scope of development services that we can provide in mRNA vaccines to prevent the diseases from developing in people in the first place.
Also the R&D centre in San Francisco provides CDO services closer to clients, and we will continue expanding to other regions globally including Boston, Europe, etc.
About the author
Seahee Kim, Ph.D. has more than 11 years of experience including the biopharma industry. She leads the cell line development at Samsung Biologics and developed over 30 cell line development projects successfully. Before joining Samsung Biologics in 2017, she was a scientist leading a research team in a biology lab at Samsung Advanced Institute of Technology and was responsible for personalised cancer medicine and DNA diagnostics research. She received her Ph.D. degree in molecular virology from the Yonsei University, Korea, and post-doctoral training in biochemistry and molecular biology at the Penn State University.